Penny C. Sharp

The estrogen replacement and atherosclerosis (ERA) study: study design and baseline characteristics of the cohort.

The Estrogen Replacement and Atherosclerosis (ERA) trial is a three-arm, randomized, placebo-controlled, double-blind trial to evaluate the effects of estrogen replacement therapy (0.625 mg/day oral conjugated estrogen) with or without continuous low-dose progestin (2.5 mg oral medroxyprogesterone acetate/day) versus placebo on progression of atherosclerosis. A total of 309 postmenopausal women at five sites underwent baseline coronary angiography and were randomized. Participants will have repeat coronary angiography after an average of 3.25 years of treatment. The primary outcome of interest will be change in minimum diameter of the major epicardial segments, as assessed by quantitative coronary angiography. The primary aim is to test the hypothesis that either form of hormone therapy will slow the progression or induce regression of coronary atherosclerosis compared to placebo. The secondary aims are to assess the effects of the two treatments versus placebo on endothelial function (measured using flow-mediated vasodilator responses), on several presumed mediators of estrogens effect on atherosclerosis (i.e., plasma lipids and lipoproteins, blood pressure, glucose metabolism, hemostatic factors, and antioxidant activity), on other factors that influence the development of coronary heart disease (i.e., diet, smoking status, exercise, weight, and health-related quality of life issues), and on clinical cardiovascular events. The ERA trial is the first angiographic endpoint clinical trial to examine the effects of postmenopausal hormone replacement on coronary atherosclerosis in women. It will provide an unparalleled opportunity to determine if either regimen of hormone therapy is effective in slowing the progress of angiographically defined coronary atherosclerosis. This study will complement other estrogen replacement trials, such as the PEPI, HERS, and Womens Health Initiative studies, to provide a more comprehensive examination of the effects of estrogen replacement on cardiovascular risk factors, anatomic and functional manifestations of atherosclerosis, and risk for coronary heart disease in postmenopausal women. Control Clin Trials 2000;21:257-285

Regional program for prevention of premature birth in northwestern North Carolina

We present our experience with introducing and implementing a prematurity prevention program in a 20-county region in northwest North Carolina. The program is based on the risk assessment and educational model. In the first 25 months of results available, 17,370 births occurred in women enrolled in the project. During 1985, 42.5% of all births in the region occurred in the project. During the time span examined, a downward trend was seen for rates of low birth weight births in public and private patients and for very low birth weight births in private patients. During 1985, private births in the project were significantly less likely to be low birth weight or very low birth weight than private births to women not in the project. These results suggest that regional implementation of prematurity prevention programs is feasible and that such programs are particularly appropriate for private patients.

Cultural Issues in the Development of Cancer Control Programs for American Indian Populations

Cancer is the third-leading cause of death among American Indians. The persistent disadvantage in cancer survival rates among American Indian populations emphasizes the importance of developing effective cancer control programs for prevention and early detection. However, substantial cultural differences between American Indians and whites can affect the success of these programs. This paper examines the concept of cultural sensitivity in the con text of developing cancer control programs for American Indian populations. It explores fundamental differences in beliefs, behaviors, and values between American Indian and white majority cultures, and presents examples of culturally sensitive health education programs. The paper highlights insights and experiences gained in developing the North Carolina Native American Cervical Cancer Prevention Project, and gives recommendations for the development of future programs.

The role of focus groups in health education for cervical cancer among minority women

Focus groups were used in the development of community-based public health education designed to reduce mortality from cervical cancer among black women in Forsyth County, North Carolina. The educational goals of this National Cancer Institute (NCI) funded project were to increase the proportion of black women, age 18 and older, who obtain Pap smears on a regular basis and return for followup care when necessary.A series of four focus groups were conducted to help develop the conceptual basis for designing educational messages and materials. The groups were led by a black, female professional focus group moderator, and explored a variety of health-related topics ranging from general, ordinary concerns of daily living to knowledge and attitudes about cancer screening.The group discussions suggested that health is regarded as very important to the target population, particularly when related to family functioning. Regarding the Pap smear, most women knew about the test, but had little awareness of its role in the early detection of cervical cancer. Fear and fatalism were clearly the dominant, top-of-mind reactions to cancer, and there was little differentiation among sites or types of cancer. Despite the overall pessimism, the groups agreed that early diagnosis and treatment provide the best hope for good outcomes with cancer.

A comparison of risk assessment models for term and preterm low birthweight

BACKGROUND Most epidemiological research dealing with the assessment of risk for low birthweight has focused on all low birthweight births. Studies that have attempted to distinguish between term and preterm low birthweights have tended to examine preterm low birthweight, since the risk of perinatal mortality and morbidity is greatest for this group of infants. METHOD This study uses data from 25,408 singleton births in a 20-county region in North Carolina to identify and compare risk factors for term and preterm low birthweights, and also examines the usefulness of separate multivariate risk assessment systems for term and preterm low birthweights that could be used in the clinical setting. RESULTS Risk factors that overlap as significant predictors of both types of low birthweight include race, no previous live births, smoking, weight under 100 lb, and previous preterm or low birthweight birth. Age also is a significant predictor of both types of low birthweight, but in opposite directions. Younger age is associated with reduced risk of term low birthweight and increased risk of pattern low birthweight. CONCLUSION Comparison of all risk factors indicates that different multivariate models are needed to understand the epidemiology of preterm and term low birthweights. In terms of clinical value, a general risk assessment model that combines all low birthweight births is as effective as the separate models.

Variable decelerations during nonstress tests are not a sign of fetal compromise

An examination of 908 fetal heart rate tests of 418 consecutive patients revealed brief variable decelerations in more than 50.7% of the patients. Although an association existed with nuchal cord location found at delivery, no association existed between these variable decelerations and fetal heart rate decelerations during labor, low Apgar scores at birth, or birth weight. We find no evidence to suggest that these brief variable decelerations are a sign of fetal compromise or an indication for obstetric intervention.

Assessment of the patient-doctor interaction scale for measuring patient satisfaction

This study assessed the validity, reliability and usability of the Patient-Doctor Interaction Scale (PDIS) in a university-based family practice center. Health maintenance visits and problem visits were included, and data were collected at the time of the visit and again 1 month later. Three different methods of administration (in-person, telephone, and mail) were used to assess usability. Of 91 patients approached, 1 refused to participate. A total of 64 (70%) patients completed the instrument adequately to permit analysis. PDIS scores correlated with overall assessment of patient satisfaction (P < 0.01), suggesting criterion-based validity. Internal consistency (reliability) of the PDIS was indicated by Cronbachs alpha which were consistently greater than 0.80. Scores and return rates varied by method of administration, with the telephone method performing best. The PDIS appears to fulfill the requirements for a valid, reliable and useful instrument to assess patient satisfaction in family practice settings.

Recruitment of Participants for the Estrogen Replacement and Atherosclerosis (ERA) Trial: A Comparison of Costs, Yields, and Participant Characteristics from Community- and Hospital-Based Recruitment Strategies

This paper documents recruitment for the Estrogen Replacement and Atherosclerosis trial, a multicenter, placebo-controlled, double-blind angiographic trial of the effects of opposed and unopposed estrogen on coronary atherosclerosis in postmenopausal women (average scheduled duration of follow-up 3.2 years). We compare costs, yields, and participant characteristics between community-based and hospital-based recruitment strategies. We further compare community-based enriched sources (i.e., those that allowed self-selection or targeted women with known health characteristics) and nonenriched sources. Data gathered on potential participants include method of contact, clinical site, eligibility, completion of screening visits, and randomization rates. Demographic data on participants include age, race, education, marital status, and income. Self-reported health status, smoking status, lipid level, ejection fraction as well as history of chest pain, hypertension, and diabetes were recorded at baseline. Recruitment costs were estimated from employee salaries and costs of screening tests and procedures. Yields were compared by clinical site and by method of contact. Enriched sources of recruitment yielded higher percentages of enrolled participants than nonenriched sources. Both types of source resulted in demographically similar participants. Costs of community-based recruitment were less than hospital-based recruitment; however, screening costs were higher. Overall, screening and recruitment averaged

The value of process evaluation in a community-based cancer control program

2508 per randomized participant. Control Clin Trials 2001;22:13-25

Identification of women at high risk for preterm-low-birthweight births

Abstract The Cancer Awareness Program was a four-year community health education project conducted in six rural North Carolina counties. The educational program was designed to increase breast, cervical, and skin cancer screening behaviors in low income women. Female clients of the health department in each county, aged 20 and older, were eligible for the program. Program intervention activities were targeted both to the health departments and to the individual women, in addition to the community. Intervention activities included media messages, telephone counseling of participants, community presentations, printed materials, bulletin boards, and direct education. Process evaluation allowed for regular monitoring of all program components, identifying any areas in need of modification, and was developed for the long distance supervision of the project as well. Measures consisted of videotaping of presentations, meetings with key individuals and staff, participant evaluations and feedback, focus groups, and weekly activity reports from staff. The results of the process evaluation enabled investigators to pinpoint effective intervention components that led to desired results. In addition, it allowed investigators to define areas in need of modification, and adjust specific components. Final evaluation of the project indicated that the intervention significantly increased participation in screening for skin cancer and breast cancer. Included in the paper are the purposes of each process method, problems identified, and their resolution. Suggestions are made for use of process evaluation in community health education programs.